Associate Manager - MSAT (C&Q)

About the Role

Join us in advancing patient care through a commitment to quality, compliance, and scientific rigor. In this position, you will play a vital role in ensuring safe and effective pharmaceutical products by managing validation and quality assurance processes.

Primary Responsibilities

• Assess, review, and authorize master validation plans, protocols, and reports to align with company protocols and regulatory standards.
• Provide expert troubleshooting for validation challenges related to equipment and process performance.
• Analyze testing data statistically, investigate process deviations, and support Quality Investigations with advanced data insights.
• Oversee preparation, review, and endorsement of validation documentation and technical reports adhering to Pfizer Quality Standards.
• Contribute actively to moderately complex projects with effective time management and planning of short-term tasks.
• Manage standard Quality systems including Change Control, Quality Agreements, documentation control, and investigations; Liaise with functional teams for coordinated testing efforts.
• Maintain the Site Validation Master Plan, facilitate regulatory audits, and represent engineering validation on site and network teams.
• Support activities related to product transfers, new product development, regulatory inquiries, cost optimization projects, and Cleaning Validation. Integrate validation scheduling into production and engage in deviation assessments.

Required Qualifications and Experience

• Educational background varies: High school diploma with minimum 8 years experience; Associate degree with at least 6 years; Bachelor's degree with 2 or more years; or advanced degrees with relevant experience.
• Demonstrated expertise in Good Manufacturing Practices (GMP) and comprehensive knowledge of quality systems and processes.
• Experience working with software platforms such as Global Document Management System, SAP, and Quality Tracking System.
• Effective communication skills, both verbal and written, with capability to work independently or collaboratively.

Preferred Skills and Knowledge

• Technical proficiency in validation and qualification of pharmaceutical processes, equipment, utilities, facilities, and computerized systems.
• Experience with sterile manufacturing and medical device compliance.
• Strong analytical thinking and problem-solving capabilities combined with organizational and time management strengths.
• Mentoring skills and experience in guiding colleagues.
• Familiarity with regulatory audits and adherence requirements.
• Practical knowledge and use of AI tools like ChatGPT or Microsoft Copilot to enhance productivity and problem-solving, along with understanding ethical AI practices and risk management.

Essential Expertise

• Preferred qualifications include degrees in Pharmacy (B. Pharm/M. Pharm), Engineering (B.Tech/BE).
• 6 to 8 years of experience in Quality Assurance, Validation, or Engineering within sterile dosage form or injectable formulations sectors catering to regulated markets.
• Comprehensive understanding of pharmaceutical manufacturing, packaging, and quality assurance operations.
• In-depth knowledge of validation principles related to manufacturing processes, cleaning methods, facilities, equipment, utility systems, and computerized system validation (CSV).
• Familiarity with equipment used in sterile manufacturing like autoclaves, vial washers, depyrogenation tunnels, filling and sealing machinery, solution preparation, filter integrity testers, inspection, and packing equipment.
• Competence in compiling validation documentation, generating facility qualification reports, preparing and reviewing qualification protocols (DQ, FAT/SAT, IQ/OQ/PQ), and ensuring timely revalidations.
• Ability to conduct alarm assessments, data analysis, deviation reviews, and problem-solving using DMAIC and other methodologies.
• Awareness of cGMP guidelines, FDA regulations (including 21 CFR part 11), GAMP requirements, PDA guidance, ISO standards, and safety protocols.

Additional Information

This position is under the Pfizer Quality Assurance and Control division. Pfizer is an equal opportunity employer, complying with all relevant equal employment laws where it operates.